CalcMyPeptide
Weight ManagementAlso known as: Imcivree, RM-493, MC4R agonist

Setmelanotide

Setmelanotide (Imcivree) is a hyper-expensive, ultra-selective MC4R receptor agonist representing the absolute pinnacle of precision genetic medicine. FDA-approved exclusively for patients with catastrophic underlying genetic mutations (POMC, PCSK1, or LEPR deficiencies), it bypasses the body’s broken metabolic hardware to manually "turn off" the starvation signal in patients who otherwise suffer from incurable, literally endless hyperphagia (extreme hunger).

Reviewed by CalcMyPeptide Editorial Team
Last updated: April 2026Evidence: High1 peer-reviewed citation

Quick Stats

Half-Life11-12 hours
Dose Range1-3 mg/day
Frequency1× daily
Vial Sizes10 mg
Bioavailability~82% (SC)
Year Developed2020

Scientific Data

Molecular Formula
C49H68N18O9S2
Molecular Weight
1117.3 g/mol
CAS Number
920014-72-8
Developer
Rhythm Pharmaceuticals

Mechanism of Action

Setmelanotide (Imcivree®) is a melanocortin-4 receptor (MC4R) agonist developed specifically for rare genetic obesity disorders caused by deficiencies in the leptin-melanocortin pathway. It directly activates MC4R in the hypothalamus to restore satiety signaling that is absent or blunted in patients with loss-of-function mutations in POMC (pro-opiomelanocortin), PCSK1 (proprotein convertase subtilisin/kexin type 1), LEPR (leptin receptor), BBS (Bardet-Biedl syndrome), or Alström syndrome genes. FDA breakthrough therapy approval in 2020. Clinical trials show 25%+ weight loss in genetically confirmed patients.

Source: PMID: 32320060 (Phase 3 NEJM)

Dosing Protocol

Typical Dose1-3 mg/day
Frequency1× daily
Half-Life~11 hours
Common Vial Sizes10 mg

Dosing Protocols

Pediatric (≥6 years)

Dose
1 mg/day → titrate to 3 mg/day
Frequency
Once daily SC (morning)
Note: Start at 1 mg/day. Increase by 0.5 mg every 2 weeks based on response.

Adult

Dose
2 mg/day → titrate to 3 mg/day
Frequency
Once daily SC (morning)
Note: FDA-approved for BBS, Alström, POMC, PCSK1, LEPR deficiency.

Administration

Route
Subcutaneous injection (abdomen)
Timing
Once daily in the morning.
Fasting Required?
No — food timing not critical

Expected Timeline

Month 1-3
Hunger reduction often dramatic in genetically affected patients. Early weight loss.
Month 6-12
Average >25% body weight reduction in clinical trials for POMC/LEPR deficiency.

Who Is It For?

Genetic Obesity Syndromes

High

FDA-approved for POMC, PCSK1, LEPR deficiency and BBS/Alström syndrome. First targeted treatment for these patients.

Reconstitution Example

Vial
10 mg
Water
2 mL
Concentration
5 mg/mL
Per Unit (100u syringe)
50 mcg
Dose of 1000 mcg = 20 units on a 100-unit insulin syringe
🧮 Calculate Your Exact Setmelanotide Dose →

Safety & Considerations

FDA-approved (Imcivree). NOT for general obesity — only for confirmed MC4R pathway genetic deficiencies. Side effects: hyperpigmentation (MC1R off-target), injection site reactions, sexual adverse events. Genetic testing required before prescribing.

Regulatory & Legal Status

FDA Status (US)
Research Only
WADA Status (2026)
Not Listed

Not currently on the WADA 2026 Prohibited List. Policies may change — verify before competition.

Classification

Research Chemical

US Compounding: Not eligible / not available

⚠️ This information is for educational purposes only and may not reflect the most current regulatory updates. Always verify with official FDA, WADA, and jurisdiction-specific sources before use.

Dosing Quick Reference

Setmelanotide— Dosing Guide
Dose Range
1-3 mg/day
Half-Life
~11 hours
Frequency
1× daily
Route
Subcutaneous
10 mg vial
💧 2 mL BAC water📐 5 mg/mL concentration💉 50 mcg/unit (100u syringe)
Weight Managementcalcmypeptide.com

Frequently Asked Questions

Can setmelanotide be used for general obesity?▼
No — setmelanotide is a targeted therapy for specific rare genetic mutations in the leptin-melanocortin (MC4R) pathway. It is ineffective and not approved for common obesity without these mutations.
What genetic conditions qualify for setmelanotide?▼
FDA-approved for: POMC deficiency, PCSK1 deficiency, LEPR deficiency, Bardet-Biedl syndrome (BBS), and Alström syndrome. Genetic testing must confirm the mutation before starting therapy.

References

  1. Clément K et al. “"Setmelanotide for obesity due to POMC or LEPR deficiency (Phase 3)".” New England Journal of Medicine (2020). PMID: 33086009

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